Founders (from the left): Piotr Sędzik, Piotr Sobusiak, Jan Kamiński

Applover: ISO 13485 certified full-stack digital agency from Wrocław, Poland

Applover - a full-stack digital agency from Wrocław, Poland, specializing in HealthTech has obtained ISO 13485 certification

By achieving this certification, we reaffirm our dedication to producing top-tier, reliable software solutions that comply with the highest industry standards.”

— Piotr Sędzik, CEO and co-founder of Applover

WROCłAW, POLSKA, July 26, 2023/EINPresswire.com/ -- Applover - a full-stack digital agency from Wrocław, Poland has obtained ISO 13485 certification. This accomplishment marks a significant milestone for the organization that creates IT solutions, e.g. for HealthTech, specializing in technologies such as Ruby on Rails, Node.js, Python, React Native, Vue, JavaScript, Flutter, Swift, or Kotlin.

ISO 13485 is an international standard tailored for organizations involved in the medical device industry, demonstrating adherence to the comprehensive requirements for a Quality Management System in the medical devices and software sector. With this prestigious certification, Applover not only meets the regulatory requirement but also gains a competitive edge and access to global markets.

ISO 13485 sets stringent requirements for quality management systems. By achieving this certification, we reaffirm our dedication to producing top-tier, reliable software solutions that comply with the highest industry standards. Our clients can trust us to manufacture products that meet all necessary regulations and exceed their quality expectations at every stage of the supply chain - Piotr Sędzik, CEO and Co-founder of Applover does not conceal his satisfaction.

Furthermore, ISO 13485 certification empowers Applover to bolster its data security measures, ensuring the confidentiality and integrity of clients' data. They can be confident that their valuable information is safeguarded against any potential cyber threats.

ISO 13485 certification process has been a transformative journey for Applover. We've fine-tuned our business processes, and optimized service, and risk management. This newfound efficiency allows us to accelerate innovation and deliver cutting-edge solutions to our clients in record time. - sums up Magdalena Błaszczak, COO of Applover.

It's worth reminding that the U.S. Food and Drug Administration has initiated the acceptance of ISO 13485 Quality Management System (QMS) audit reports from manufacturers through the Medical Device Single Audit Program (MDSAP). This step significantly influenced the agency's choice to proceed with the proposed QMSR rule.
‘FDA intends to converge its requirements with quality management system requirements used by other regulatory authorities. FDA seeks to accomplish this primarily by incorporating by reference the 2016 edition of International Organization for Standardization (ISO) 13485 (ISO 13485)’. (source: www.federalregister.gov)

Our commitment to quality and compliance opens doors to exciting opportunities and partnerships worldwide. Quality assurance and regulatory compliance are paramount in the healthcare domain. ISO 13485 certification isn't just a badge on our website; it represents a commitment to long-term growth and customer trust - emphasizes Jan Kamiński, CSO and Co-founder of Applover

The announcement that the FDA plans to use ISO 13485 as the basis for its quality system legislation signals an important step forward for the international standard, which is already widely used globally. Healthcare industry manufacturers that already address ISO 13485 standards will have a leg up to address FDA regulations.

We're incredibly proud of our ISO certification, and we're excited about the positive impact it will have on the healthcare industry. Our mission to create innovative and impactful software solutions remains stronger than ever, and this certification gives fuel to push boundaries and propel healthcare forward through technology - declares Piotr Sobusiak, CTO and Co-Founder of Applover.

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Applover is a Full-Stack Digital Agency based in the city of a hundred bridges. Our DNA is to work on technologies for the most dynamic and recognizable start-ups in the domestic and global markets. We started in 2016 as a group of 4 friends and technology enthusiasts, and now, we operate as a group of 140 experts. To date, we’ve successfully developed over 220 projects. A testament to our commitment to quality is our ISO 13485 certification, emphasizing our role in developing excellent medical software. Applover was recognized by Financial Times in the “FT 1000” ranking in 2023 and Deloitte as a Rising Star in the CEE region in 2019 and ranked in the Fast 50 category in 2020 and 2021.

Our notable partnerships include KiloHealth, Nokia, Callpage, Lettly, Slock.it, Steppie, Market Supply, Bigvu, Prismade (edding), Labplus, Amino, Foodsi, Signium, Ticketing.Co, and ETH Zurich.

However, the opinions of our customers on Clutch are the best proof of our services.
Interested in what we developed for our clients? Go to our case studies.

Artur Ragan
Applover Sp z o.o.
artur.ragan@applover.pl
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